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31 Ponatinib (Iclusig, Ariad Pharmaceuticals, Cambridge, MA)—designated for priority review and orphan status, and granted accelerated approval was approved for refractory chronic myeloid leukemia in 2012 and its approval was suspended a year later as emerging data showed it to be less safe than it originally appeared.
This marked the first time a so-called "cancer vaccine" had been approved and, although Provenge offered only modest survival benefits, its approval was hailed as a major advance that might open the door to other therapies that harness the immune system to fight cancer [ 31].
As the biosimilar regulatory pathway was not available for this product, it is not considered a 'biosimilar' in the USA; however, its approval was sought through the separate regulatory pathway 505(b)(2) that uses scientific and regulatory principles consistent with the biosimilar pathway 25.
Its approval was also withdrawn.
In a letter sent to AT&T last week, British Telecom said its approval was required for the breakup.
The most Janka could muster from his hunched position as the crowd roared its approval was thrusting his right thumb into the air.
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Congress has to be notified to allow discussion in private among members who are interested, but its approval is not required and it does not normally block such transfers.
Nonetheless, its approval is anticipated.
Its approval is followed by review at the cantonal and federal levels.
Its approval is far from certain.European critics complain that the deal gives too much ground to the Americans.
However, its approval is based on an environmental study the US Forest Service conducted more than 25 years ago, in 1986.
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